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Across most jurisdictions today, researchers who propose to involve humans must first submit an application form to one or several committees of experts, who then assess the ethics of the proposed research. As a result of central role in determining the bounds of ethical research, Research Ethics Committees have been subject to sustained scrutiny. The cumulative charge is that research ethics review by committees promotes a wicked combination of inexpert review, inconsistent opinions, duplicative work, mission creep and heavy-handed regulation of health research. This chapter places this charge at the focal point. In what follows, I chart the process of research ethics review with a view towards arguing that RECs have become regulatory entities in their own right and very much are a form of social control of science. As I detail, while RECs are far from perfect in terms of regulatory design and performance, they do perform, at least in principle, a valuable role in helping to steward research projects towards an ethical endpoint. This chapter also offers a critique of existing work and suggests some future directions for both the regulatory design of research ethics review and also researching the field itself.
In this chapter we focus on social value in health-related research involving humans, including data driven research. We find that to state a requirement for social value is one thing; to actually evaluate the social value of a research project in a Research Ethics Committees (REC) is another. We therefore elaborate on how the requirement of social value can be applied. We argue, first, that it is important to have this requirement as a separate condition. To increase systematisation, we further discuss how social value can be assessed in the steps that together constitute the risk-benefit task of RECs. We argue that the addition of the requirement of social value can be seen as a consequence of a change in the sociology of science. It illustrates the move away from a science-internal understanding of scientific validity into an inclusive understanding of social value. Accepting social value as a requirement for research to be evaluated by a REC means that social value has matured from an attractive but illusive idea into something that has to be assessed, evaluated and optimised and can be used to address some of the justice issues in healthcare.
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